Recently, the Singapore Medical Devices Cluster promulgated a draft regulation for a Change Management Program (CMP) for SaMD products – for industry feedback. The discussion for this proposed regulation is from August 26 to October 21. Singapore, being a very advanced healthcare system, wants to help facilitate the use of SaMD products in a way that “changes” to these products can be easily accepted or registered quickly and put to use by healthcare providers to aid their patients.
The CMP system helps expedite changes in SaMD products by counting on the SaMD manufacturers’ high-quality standards shown through their validation, verification, and post-market surveillance programs. The CMP system has also outlined a Pre-Specified Change (PSC) program that allows expected SaMD changes to be anticipated and carried out efficiently. Following this PSC program, for SaMD products that have already been approved, a future registration for a related SaMD product with an equivalent QMS can use earlier submitted CMP documents – reducing the need to resubmit the same documents again. If approved, the CMP will be included into Singapore’s HSA’s Premarket Submission and Change Notifications processes. SaMD products used for diagnosis, investigation, treatment, or monitoring of a person’s health will be eligible for this program. Changes to SaMD products that change the intended use, indication, and other significant changes will not be eligible for this program. To learn more about this proposed Guidance, please see this link – Guidance on Change Management Program for SaMD_For consultation.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.